Novartis Heart Drug Misses Key Target in Trial
Pelacarsen failed to reduce major cardiovascular events in a late-stage trial, sending Novartis shares down 16%.
Updated on Nov. 2, 2026 in Heart Disease
Novartis's pelacarsen did not meet its primary endpoint of reducing major cardiovascular events in a Phase 3 trial, despite lowering blood levels of lipoprotein(a), or Lp(a), by 80%. Novartis shares fell 16% following the announcement.
Why it matters
Lp(a) has been a widely studied target for heart disease risk, and the trial result tests whether lowering it translates into fewer heart attacks and strokes. Doctors noted that stroke was included in the composite endpoint even though its link to Lp(a) is unclear.
The Phase 3 trial, which tested an 80 milligram monthly dose for the first time, reported an 80% drop in Lp(a) levels versus placebo but no reduction in the composite endpoint of death, heart attack, stroke, and revascularization. Full results are still pending and have not yet been presented in detail.
The players
Novartis
The Swiss pharmaceutical company developing pelacarsen, whose shares fell 16% after the trial failed its primary endpoint.
American Heart Association
The U.S. nonprofit that issued guidance recommending Lp(a) testing for all adults and is hosting the presentation of the full trial results.
Amgen
The biotechnology company developing olpasiran, a competing Lp(a)-lowering drug with Phase 3 results expected in early 2028.
Eli Lilly
The pharmaceutical company developing lepodisiran, another Lp(a)-lowering drug with results expected in 2029.
The details
The trial compared pelacarsen against placebo in patients also receiving LDL-lowering statins and PCSK9 drugs, measuring a composite of death, heart attack, stroke, and need for revascularization procedures. Detailed results will be presented Saturday in Chicago at the American Heart Association annual scientific meeting.
Timeline
• 2019: Phase 3 pelacarsen trial launched
• Earlier in 2026: AHA and American College of Cardiology issued guidelines recommending all adults have Lp(a) measured at least once
• Saturday, November 2026: Full trial results presented at the AHA meeting in Chicago
• Early 2028: Amgen olpasiran Phase 3 results expected
• 2029: Eli Lilly lepodisiran results expected
Big Picture
The failed trial arrives just after the AHA and American College of Cardiology recommended that all adults have Lp(a) measured at least once, a guideline built on the premise that lowering this genetically driven risk factor would help. Rival Lp(a) drugs from Amgen and Eli Lilly, which lower levels by around 95%, now face the question of whether that deeper reduction produces better outcomes.
Because Lp(a) levels are genetically determined and not affected by diet, exercise, or lifestyle changes, the trial result does not change current options for lowering this risk through daily habits. Patients should discuss Lp(a) testing with their doctors, since the new guidelines recommend it for all adults.
The takeaway
A single lab test can reveal a genetically inherited heart risk that lifestyle changes cannot alter, so asking your doctor about measuring Lp(a) is a practical step worth considering. The pelacarsen result shows that lowering a risk marker does not automatically prevent heart attacks and strokes.
What happens next
Full pelacarsen trial results will be presented Saturday in Chicago at the AHA annual scientific meeting, with Amgen's olpasiran results expected in early 2028 and Eli Lilly's lepodisiran results in 2029.
Further reading
For more on the conditions this research targets, explore our Heart Disease coverage.
Source note: This article includes information reported by Medscape.
